Friday, May 21, 2021

How this MICRO IMPLANT RADAR revolutionized breast cancer surgeries

 INTRODUCTION

For surgical procedures of breast cancer, NYCRANEWS explores wire-free Radar Localization - a pre-surgical procedure to locate and mark the exact breast abnormality through the use of a small, 12×1.6 mm implanted radar reflector device, roughly the size of a grain of rice. This micro-electronic implant communicates with the scanning handpiece, allowing the surgeon to identify the exact tissue (and how much of it) to extract during a lumpectomy [1]. The early process of localization came in the form of a guide wire insert but later advancements offered other solutions including a wireless radioactive seed and (then) a non-radioactive version called SCOUT®- formerly called SAVI-SCOUT (until July, 2019) [2]. It was developed by Cianna Medical and then acquired in 2018 by Merit Medical, an American medical technology company. 

Publishers of FightRecurrence.com and PinkSmart News dedicated a review of this surgical solution in support of improvements in the preservation of the breast during surgery.  In this feature article, we present Dr. TroyShell-Masouras of Paradise Coast Breast Specialists in Naples Fla. - and David Gilstrap, Director & Global Product Management of Merit Medical. Together, we explored technical perspectives and design strategies behind radar localization and the SCOUT® technology.  They shared the procedural advantages provided by the wire-free upgrade as well as its overall improvements to the patient's well-being in the pre and post-surgical phases.

 

WIRE-FREE UPGRADE IN LOCALIZED IMPLANTS
This segment is from Mr. David Gilstrap's 5/2021 interview.

The concept of SCOUT® wire-free radar localization was developed by Cianna Medical in 2010 and was an alternative to the predominant guide wire concept.  The launch of the SCOUT® introduced "going wire free" for the patient, providing a huge impact on patient satisfaction. Prior to this, the original process included placing a wire in the patient the day of  surgery, and the patient maintains this wire sticking out of their breast until surgery time, which could be up to several hours.

The genesis of the non-radioactive reflector came about in 2010 as the company started re-evaluating the breast surgery localization space, because at the time there were only two other options available;  the guide wire solution (standard for 50+ years) and the radioactive seed alternative. Despite its advantages, the radioactive seed solution showed its own set of limitations and regulatory issues, limiting its public acceptance.  "It needed a lot of training and tracking and was restricted to a limited time where you can actually place it."

By December 2014, Cianna Medical received FDA Clearance for the first generation of SCOUT®  allowing full commercialization in the U.S, and CE Mark for Europe would follow. The implant is technically called the reflector. It doesn't transmit a signal, but actually reflects a signal that's being sent to it. It has its own electronic circuitry, an antenna and it is sealed with a bio-compatible coating called APTEK. There's no power source or moving parts in the reflector- it's inert. With FDA long-term implant status, when it's placed into a patient,  there are no limitations on removal and it can remain in the patient forever. It doesn't have to be removed again. There's no risk to the patient or the area of interest.

Once placed into the region for surgery, the surgeon uses the SCOUT®  surgical guide which transmits pulsating infrared light and a pulsating radar signal (at 50 million pulses/sec). This infrared light activates the reflector which bounces the radar signal back to the system, giving an audible cadence when detected as well as distance measurements from the end of that guide, accurate to one millimeter. To simplify, the technology is very similar to the micro power impulse radar used in your backup sensors in automobiles. So it is very accurate in detecting things over very short distances.

Merit attributes their success in tech feature upgrades to collected end user data from the surgical community. Prototypes are underway for a reduced reflector size, advanced image guidance, customized targeting cadence and improved ease of use in installation  Since SCOUT® is approved for soft tissues it is rapidly expanding into other surgical sites such as pulmonary nodules and soft tissue sarcomas.



Dr. Barry Rosen, breast surgeon at Good Sheppard Hospital (Chicago, IL) describes the many advantages of wire-free localization technology in oncoplastic surgery. For the patient, this innovation adds a new level of ease and adaptability over the traditional (pain and stress of) the wired version.



 

 

 

 





FROM THE SURGICAL FIELD
Breast surgeon Dr. Troy Shell-Masouras expands on the benefits of the wire-free (non-radioactive) radar  in comparison to the former solutions like the localization wire and radioactive seed. This segment is excerpted from Dr. Shell-Masouras' direct interview in 5/2021.

Initially, the first breakthrough into a wireless approach was the radioactive seed - technology that was well-known in prostate cancer. These pellets can be placed into the breast in a similar fashion where the SCOUT reflector would be placed. Once installed, you would use a probe that detects the signal of the seeds. The issue here is that because it is radioactive, there are very strict monitoring and nuclear medicine guidelines on this process as far as its retrieval. To describe this a different way, imagine inserting this radioactive seed in a patient before their surgery-- then if that patient gets into a car accident or disappeared in some way, your entire radioactive seed program could be shut down because you have to be able to retrieve that seed.

There are limitations on how long that seed is active and detectable. Because of these issues, products like SCOUT were developed where there are no limitations on the activity of the device. Time is of no concern if your patient grows ill and their procedure is postponed a month or so down the road. There's no urgency to retrieve the product at any time. These real-life situations are really why products like this are developed.

Comparatively speaking, there appears to be no difference in accuracy between the wired solution, the radioactive seed and the SCOUT. The radioactive seed is significantly smaller than the SCOUT  but this size difference is a non-issue to surgeons. Statements about SCOUT’s (minor) limitations however mention a slight adjustment in work parameters around the distance between the skin and the device particularly with large breasts or very dense breasts. The SCOUT technology is something that continues to evolve... they are trying to develop where you have a different signal if you have more than one lesion from multiple markers within the breast. Merit is also leading to a lot of competition because everybody wants a piece of that wire free action- but the SCOUT developers set the bar pretty high and a lot of institutions have embraced it... I think it's going to be tough for them to break in since SCOUT has already made their mark.

It is noted that programs using radioactive seeds continue to exist, but the market appears to reflect a transition to non-radioactive devices for reasons described.

Dr. TroyShell-Masouras conducts life saving Breast Cancer Surgery at Paradise Coast Breast Specialists in Naples Fla.  Dr. Shell-Masouras specializes in the diagnosis and treatment of breast cancer and benign breast disease, and provides high risk breast cancer assessments, breast ultrasounds, ultrasound-guided breast procedures to include biopsies and aspiration, partial mastectomy and lumpectomy, total mastectomy to include Hidden Scar™ Breast Conserving Surgery and Hidden Scar™ Nipple Sparing Mastectomy, sentinel lymph node biopsy, axillary lymph node dissection, and radar localization for lumpectomies.


VIEWPOINTS

STEPHEN A. CHAGARES, MD FACS- Cancer Surgeon/ General,Laparoscopic, Robotic Surgery -  Yes, the Scout technology is a great progression of technology. It allows accurate localization with site of incision at the Surgeon’s discretion allowing for significantly increased cosmetic appearance of a lumpectomy. Also, it’s placed days earlier so no radiology delays on OR days waiting for patients to return after being sent down for guidewire placement." 

* Opinions expressed in this VIEWPOINTS section are supportive comments about the contents of this article and are solely those from the contributors credited.









The Male Breast Cancer Coalition presented the work of  Dr. Jose Pablo Leone, medical oncologist and researcher at the Dana-Farber Cancer Institute about his research plans covering tamoxifen and aromatase inhibitors for the treatment of male breast cancer.  While women have the benefits of switching to AI should they contract side effects from Tamoxifen, men are in a harder situation when making this decision because not enough data about the efficacy of aromatase inhibitors (AI) are available for men. 

"Currently, only retrospective studies are available out there, which are prone to selection bias. We need to do more research to get scientific validity to dictate treatment for patients.   Due to the physiological differences in the endocrine system between men and women, there may be differences in the efficacy of aromatase inhibitors, leaving men with only Tamoxifen as their primary option.  Tamoxifen for men is the standard recommended drug for men with metastatic breast cancer. If there is progression of disease after Tamoxifen, then other endocrine therapies can be used in the metastatic setting. This is why we need prospective studies evaluating AI in men."  (See complete article)    



BREAST CANCERSCAN NEWS: From the International Oncology Community (Comunit√† Oncologica Internazionale)

4/30/2021 Dr. Robert Bard has been elected as the Sr. Medical Advisor of the Integrative Cancer Resource Alliance- an international community of diagnostic imaging specialists.  His educational presentation has been translated in over 5 different languages for the world stage, supporting partners in The Netherlands, Italy, France and Germany.  This 2021 report recognizes the advancements in non-invasive, real-time diagnostic imaging of cancer tumors for tracking, monitoring, screening and dual diagnosing as well as preop and image guiding intervention during procedures.  Dr. Bard identifies the global movement and demand for virtualization- a medical innovation for remote multi-disciplinary collaboration (ie, TeleRad, Tele-Health and Virtual Conferences) to support the expansion of data sharing  as a modern paradigm of problem-solving in cancer care. 

In an earlier feature, Dr. Bard celebrates the global solidarity of cancer imaging scientists including the work of some of his most respected research colleagues including Professors Luigi Solbiati, Carlo Martinoli, Rodolfo Campani. These are just some of the many highly regarded members of the pioneering community who helped pave the movement for a much improved detection of cancer tumors and other subdermal disorders. 

(Image-L) Once you have a vascular map of the cancer, we have the initial vessel density of 4.5%. Successful treatment over weeks or months will bring it down. In this case, it's down to one quarter of the initial treatment so this is treatment success. This is quantitative mapping of treatment follow-up because if it's working, it's better to change treatment, to avoid the side effects of chemo or other immunotherapies.  The first circle on top shows the red tumor vessels. The 4D Instagram computer reconstruction gives you a quantitative measure of how many tumor vessels are present. Once you have a number, you can follow the number up or down to verify treatment success or failure to adequately adjust treatment that's needed up or down. (For complete review of CLINICAL IMAGING OF BREAST CANCER Explained, visit: breastcancernyc.com)


GET CHECKED NOW! : EARLY DETECTION SAVES LIVES

According to the 
World Health Organization, early detection of cancer greatly increases the chances for successful treatment. In the ongoing battle against cancer, it is common knowledge that most cancers in their early stages are far more likely to be treated with positive results. Moreover, a thorough checkup of one's physiological analyses, heredity review and personal data gathering are all strong info-gatherings for early warning signs that someone may be a candidate for cancer. PROACTIVE tasking starts from AWARENESS, EDUCATION & REGULAR SCREENINGS. The right attitude of self-preservation and an appreciation for longevity is lesson #1. Pursuing a balanced lifestyle covering all the bases of nutrition, exercise, sleep, detoxing and de-stressing is also part of an overall plan for better quality of life. Also visit: www.FightRecurrence.com

 


References:

1) "What is Breast Needle Localization?"  https://myhealth.alberta.ca/Alberta/Pages/Breast-needle-localization.aspx#:~:text=Needle%20localization%20(also%20called%20wire,by%20mammogram%20or%20ultrasound%20guidance.

2) July 2019: "Exciting Changes are Here for SCOUT Radar Localization: Merit medical is excited to announce that SAVI SCOUT will now be known as SCOUT radar localization...  ": https://www.merit.com/wp-content/uploads/2020/07/SCOUT-Report-2019-July-Changes-for-SCOUT-Radar-Localization.pdf

3) Savi Scout- a Surgeon's Perspective (SAVI SCOUT News/ CiannaMedical Newsletter)- https://www.merit.com/wp-content/uploads/2020/09/201808-SCOUTReport-ASurgeonsPerspective.pdf

4) Introducing the New SCOUT Ultrasound Delivery System (SAVI SCOUT News/ CiannaMedical Newsletter)-: https://www.merit.com/wp-content/uploads/2020/09/201812-SCOUTReport-IntroducingTheNewSCOUTUltrasoundDeliverySystem.pdf

5) Seasoned Leader Appointed to Guide / Merit’s Cianna Medical Franchise (SCOUT REPORT-News) https://www.merit.com/wp-content/uploads/2020/07/SCOUT-Report-2019-February-Seasoned-Leader-Appointed-to-Guide.pdf


Disclaimer & Copyright Notice: The materials provided on this website are copyrighted and the intellectual property of the publishers/producers (The NY Cancer Resource Alliance/IntermediaWorx inc. and Bard Diagnostic Research & Educational Programs). It is provided publicly strictly for informational purposes within non-commercial use and not for purposes of resale, distribution, public display or performance. Unless otherwise indicated on this web based page, sharing, re-posting, re-publishing of this work is strictly prohibited without due permission from the publishers.  Also, certain content may be licensed from third-parties. The licenses for some of this Content may contain additional terms. When such Content licenses contain additional terms, we will make these terms available to you on those pages (which his incorporated herein by reference).The publishers/producers of this site and its contents such as videos, graphics, text, and other materials published are not intended to be a substitute for professional medical advice, diagnosis, or treatment. For any questions you may have regarding a medical condition, please always seek the advice of your physician or a qualified health provider. Do not postpone or disregard any professional medical advice over something you may have seen or read on this website. If you think you may have a medical emergency, call your doctor or 9-1-1 immediately.  This website does not support, endorse or recommend any specific products, tests, physicians, procedures, treatment opinions or other information that may be mentioned on this site. Referencing any content or information seen or published in this website or shared by other visitors of this website is solely at your own risk. The publishers/producers of this Internet web site reserves the right, at its sole discretion, to modify, disable access to, or discontinue, temporarily or permanently, all or any part of this Internet web site or any information contained thereon without liability or notice to you.




Thursday, August 8, 2019

FROM CANCER LINK SUSPICION TO GLOBAL RECALL: BREAST IMPLANT ALCL REVIEW - THEN AND NOW


Introduction
The FDA (US Food & Drug Administration) first identified a possible association between certain breast implants and the development of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in 2011 [1]. On July 24, 2019,  ALCL advocacy groups and the global community of implant users finally achieved the long awaited recognition about this emergent disorder when the FDA announced Allergan's voluntary recall of their textured implants.  Such a recall raises a level of urgency about the public health risks behind BIA-ALCL with the hopes that other manufacturers would soon follow this lead.  "Whenever a company accepts responsibility to pull a risky product from the market, they usually aim to correct product flaws to eliminate public health risks. Recalls also set a great precedence for new research that can add to our scientific understanding about preventing the disorder and other paradigms like it", states implantscan.org.

Note that ALCL is not breast cancer - it is a type of non-Hodgkin’s lymphoma (cancer of the immune system) that in most cases is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body [1].  A significant number of cases are recorded to appear within 8-10 years after implantation but new reports are showing symptoms earlier.  A recent report from the American Society for Aesthetic Plastic Surgery states that the first symptom of BIA-ALCL is usually a swelling of the breast between 2 to 28 years after the insertion of breast implants, with an average of about 8 years after implantation.  A theory that the increased surface area of textured implants allows a higher number of bacteria around the implant, which forms a biofilm in some patients, and can result in chronic inflammation, ultimately leading to a proliferation of lymphocytes. [2]

A SURGEON'S REVIEW
Feat. Dr. Patricia Clark
PinkSmart News conducted an interview by late 2018 with Dr. Patricia Clark of Ironwood Women's Centers and the Ironwood Cancer and Research Centers in Scottsdale, AZ.  She provided great insight on various breast-related cancer topics, and she also helped clarify many areas of the BIA-ALCL associated Lymphoma crisis.  Dr Clark is a respected nationally recognized onco-plastic (reconstructive) surgeon. These surgeries plastic surgery techniques like breast lifts or breast reductions with cancer surgeries to conserve the breast and reconstruct the defects without implants.  Hence, if she performs a lumpectomy for breast cancer, rather than leave a lumpectomy defect or a deformity in the breast, she can modify techniques used during cosmetic breast lifts and reductions to fill the hole, repair the defect and prevent deformity. She might even operate on the other side so that the two match. She teams with leading board certified plastic surgeons to ensure patients have access to the full range of both mastectomy and partial mastectomy reconstructive options. 

Dr. Clark and others speculate the true number is of BIA-ALCL cases is likely under-reported to the FDA registry. Incidence estimates range from 1:3817 patients to 1:30,000. The treatment of BIA-ALCL that has not spread beyond the capsule of the implant is simply to remove the capsule and replace the implant. Because it forms in a different manner than other primary non-Hodgkin lymphomas that arise in lymph nodes, chemotherapy and radiation therapy are rarely necessary unless diagnosis is delayed and the disease has spread beyond the capsule. There are likely patients with implant problems who have had the implant and capsule removed, and for which a thorough pathologic examination may not have been done, but for whom the patient’s surgery was curative. Because of increased awareness, this is less likely to happen now than in early years.  A quick raise of hands to see who had treated a case by the hundreds of reconstructive plastic surgeons attending the 2018 BC3 meeting sponsored by Georgetown University resulted in more than 20 surgeons who had personally seen or worked with ALCL cases. At that time, records showed less than 500 cases being reported internationally with 16 deaths from over 30,000,000 implant placements. 



A capsule is tissue laid down around the implant that is part of the body's normal process of walling off any foreign body.  In addition, the formation or buildup of seroma fluid doesn't mean a patient is going to get cancer. That clear fluid that appears during injury or infection, or in the case if implants, is the body’s reaction to a foreign matter and to large, raw, cut areas of tissue.  Hence, every single breast implant, whether it's smooth or textured, forms this capsule. When capsule become too thick, contract, develop persistent seromas, or start to deform the implants, plastic surgeons remove and replace the implants and perform a capsulectomy- the surgical removal of scar tissue and capsule.  In doing so, this complete removal procedure inadvertently treats the disease successfully since the lymphoma is usually confined to just the capsule.

THE TEXTURED IMPLANT DILLEMMA
Manufacturers developed textured implants as an upgrade to the smoother counterpart.  Smooth implants would result in the shrinking of collagen and the fibers, leading to shrinkage and eventually causing the implants to become hard as a rock and painful. Textured implants were designed to prevent this while accommodating many shaped implants from rotating or shifting over time. Some shapes are thicker on the bottom, thinner on the top, and more teardrop-shaped like a breast. With textured implants, one Because of the texture, a leading theory of cause of BIA- ALCL is the high amount of surface area with more little nooks and crannies can trap more bacteria, which causes more immune cells to move in (lymphocytes) which are subjected to prolonged inflammation and can become cancerous. Other theories include allergic reactions associated with textured implants, and genetic factors.

BIA-ALCL may occur in all implants, smooth as well as textured, but most are associated with Allergan Biocell textured implants. These have now been recalled from the market. Since the risk of development of BIA-ALCL is so low, the FDA does not recommend removal of these implants if there is no swelling or pain. If a patient develops a seroma or fluid around the implant, this should be sampled and sent for pathology evaluation.

A current update of an estimated 1 in 30,000 textured implant risk has been reported and 573 unique and pathologically confirmed BIA-ALCL cases worldwide related to breast implants [3]- according to Dr. Clemens at the July 2019 review with the American Society of Plastic Surgeons.  But prior to this year’s recall, the use of textured implants remained prevalent and the risk figures showed an inconclusively low number and did not warrant any public safety action or manufacturer’s recall. 

“BIA-ALCL is not the same disease as the lymphomas that you see spontaneously arise in lymph nodes in the general public. It's not a disease that you treat with chemotherapy or radiation. This is somewhat limited to the implant capsule in most cases. Proportionately speaking, it is very rare … it can invade the local tissues you can have wide-spread disseminated disease or, but that's stunningly rare.”

Dr. Clark’s most recent experience with an ALCL case emphasizes the multidisciplinary care patients receive. This included radiology, pathology, medical and radiation oncology and plastic surgery. Capsules must be completely removed and are often densely adherent to the chest wall and even the periosteum (lining) of the bone of the rib. This increases complexity and difficulty in removing every single piece of it.  She recently collaborated with Scottsdale plastic surgeon Dr. Joe Berardi due to his previous experience with BIA-ALCL and meticulous approach to capsulectomies.

In summary, it is believed that the two strongest factors that provoke breast implant related lymphomas included formation of a BIOFILM; an infectious coating of bacteria embedding themselves in the surface of the implant. This biofilm recruits the immune cells, which develop the cancer.  Also, research have found immune-mediated or allergy-like eosinophils, indicating there could be an allergic component to development of ALCL.   

Biofilms are not penetrated by antibiotics and are poorly penetrated by immune cells which can result in chronic, sub-clinical infection that the body and antibiotics can’t clear.  The capsule is a physical barrier between the implant and the normal breast tissue within which it has been inserted.



THE RECALL: LANDMARKING A GAME-CHANGER
Each time a product is recalled, it reflects upon the manufacturer’s aim to rectify a known issue that could cause eventual harm to the consumer. The community of implant users and medical professionals have viewed enough cases (and fatalities) of BIA-ALCL historically that the July 24 recall marks a significant touchdown toward the industry’s recognition and global restitution of the possible disaster that this product has yet to face. “It validates the seriousness of the situation, because the layperson can understand that a company doesn't do that… (unless) there's a serious problem”, says Jennifer Cook of BIAALCL.com.

“I’m grateful for the chance that future women will develop this lymphoma has been greatly reduced. Its not only Allergan implants that create the risk, but it does appear from current data that their implants create the highest risk, and so with those implants being removed from the market, its going to greatly reduce the number of new cases of this disease being created. There's obviously a lot more work to be done but it is the first step, and an additional part of that equation for me was just awareness because all the women out there with this lymphoma, or the implants that can create it, still in their bodies right now, may have no idea about this lymphoma because no one is obligated to warn them. So any immediate attention potentially can reach them and so the withdrawal created more media attention and then hopefully, more awareness.”


BREAKING NEWS!
By: Jennifer Cook (BIAALCL.com)

August 8, 2019 – A new article has been published out of MD ANDERSON in a Modern Pathology Journal addressing the proper way to evaluate and sample an implant capsule that has been removed from a patient suspected of Breast Implant Associated ALCL.  The article indicates that the disease can often be missed if proper and thorough evaluation of the capsule is not done.  Not only can the disease be missed but often positive margins of lymphoma on the implant capsule can be missed and this can create a risk of incomplete resection of the disease w/c increases the risk of recurrence and worsens the patient's prognosis.  Therefore, a person who is suspected of having BIA-ALCL should have their surgeon and pathologist become aware of these latest new recommendations on proper pathology protocols so they can benefit from the state of the art information on how to diagnose and treat this disease.  (See complete report: https://www.nature.com/articles/s41379-019-0337-2)

source


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CONTRIBUTORS / TECHNICAL ADVISORS
Patricia Clark, MD, FACS is a board-certified general surgeon with a passion for treating breast cancer and for using oncoplastic surgery to improve outcomes. Additional plastic surgery training led her to become nationally recognized as a teacher of oncoplastic surgery at national and international conferences. These techniques reduce the need for mastectomy in patients with complex breast disease and they minimize deformity. She is an active member of the American Society of Breast Surgeons, the Society of Surgical Oncology, the American College of Surgeons, the National Consortium of Breast Centers and the American Society of Breast Disease. She currently practices at the Ironwood Women's Centers in Avondale AZ. (www.ironwoodwomenscenters.com)

Jennifer Cook was diagnosed with Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in August of 2017- which started her on a road to major research to collect all information about the disorder as well as seek out an international social media group of fellow survivors and a supportive community (www.BIAALCL.com). Today, Jennifer stands as one of the top advocates of the group, conducting outreach efforts to seek out other victims of this health issue. She is also an active voice in many leadership circles dedicated in the fight to bring public recognition and corporate accountability to this crisis. (See Jennifer's interview on Survivor Stories)

EDITORIAL TEAM 
Robert Bard, MD, PC, DABR, FASLMS has paved the way for the diagnostic study of various cancers both clinically and academically. His main practice in midtown, NYC (Bard Diagnostic Imaging) uses the latest in digital Imaging technology which has been also used to help guide biopsies and in many cases, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered Sonograms, Spectral Doppler, sonofluoroscopy, 3D/4D Image Reconstruction and the Spectral Doppler are safe, noninvasive, and does not use ionizing radiation. His commitment to lead the community of cancer imaging and diagnostic experts has led to the establishment of the "Get Checked Now!" campaign.

Cheri Ambrose is a co-editor for various publications such as PinkSmart News, the Journal for Modern Healing and First Responders Cancer News.  She is a patient advocate for many cancer-related programs and often contributes her time in cancer research fundraising events.  As the communications director for the NY Cancer Resource Alliance, she manages community outreach, partnership missions with other cancer foundations and research organizations and attends educational functions for cancer awareness. Her latest public projects include the launch of ImmunologyFirst.org and ImplantScan.org.  She stands as the current President of the male Breast Cancer Coalition (MaleBreastCancerCoalition.org).

3) American Society of Plastic Surgeons: BIA-ALCL Resources | By the numbers, and what they mean. By Mark Clemens, MD https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources/by-the-numbers
4) Modern Pathology:  https://www.nature.com/articles/s41379-019-0337-2

Disclaimer & Copyright Notice: The materials provided on this website/web-based article are copyrighted and the intellectual property of the publishers/producers (The NY Cancer Resource Alliance/IntermediaWorx inc. and Bard Diagnostic Research & Educational Programs). It is provided publicly strictly for informational purposes within non-commercial use and not for purposes of resale, distribution, public display or performance. Unless otherwise indicated on this web based page, sharing, re-posting, re-publishing of this work is strictly prohibited without due permission from the publishers.  Also, certain content may be licensed from third-parties. The licenses for some of this Content may contain additional terms. When such Content licenses contain additional terms, we will make these terms available to you on those pages (which his incorporated herein by reference).The publishers/producers of this site and its contents such as videos, graphics, text, and other materials published are not intended to be a substitute for professional medical advice, diagnosis, or treatment. For any questions you may have regarding a medical condition, please always seek the advice of your physician or a qualified health provider. Do not postpone or disregard any professional medical advice over something you may have seen or read on this website. If you think you may have a medical emergency, call your doctor or 9-1-1 immediately.  This website does not support, endorse or recommend any specific products, tests, physicians, procedures, treatment opinions or other information that may be mentioned on this site. Referencing any content or information seen or published in this website or shared by other visitors of this website is solely at your own risk. The publishers/producers of this Internet web site reserves the right, at its sole discretion, to modify, disable access to, or discontinue, temporarily or permanently, all or any part of this Internet web site or any information contained thereon without liability or notice to you.

Saturday, September 22, 2018

CANCER 101: The Essentials of How Cancer Happens (and Doesn't)

CANCER MADE EASY: GENETICS & MUTATIONS
By Dr. Patricia Clark

Our DNA and our genetic material is breaking and being damaged every single day. That's just the wear and tear of life. Our bodies have genes and mechanisms to repair broken DNA, and our immune systems have mechanisms to identify and destroy cancerous cells. With breast cancer, 5% to 10% of people have a genetic predisposition that raises their risk of development of breast cancer.

If we have a cell that can't be repaired, our immune system can recognize it and our natural killer cells can destroy it. So that's how things ought to work. Eventually, you accumulate MUTATIONS over a lifetime as more genes and genetic information are damaged and break down. Somebody like Angelina Jolie had a gene that predisposed her to get breast cancer. She had a gene called BRCA which is a DNA repair mechanism gene. She had one copy of that gene that did not work causing an 87% chance she was going to get breast cancer. She decided with a risk this high for the particular genetic mutation she had, she was going to get mastectomies and remove her ovaries, which were also at risk.

Genes are like a paragraph of instructions that tell a cell what it is supposed to do, such as what proteins it should make. If all the letters in the instructions are in the correct order, or the gene is “spelled’ correctly, the gene can be read by the cell and everything works. Pathologic mutations in genes have to occur in very specific locations for a cell to no longer be able to understand the instructions it carries. We have all read paragraphs where letters or words are left out, but we can understand the meaning of the paragraph. 

Changing the letters at a key location though, can change the entire meaning of the paragraph of instructions. For instance, If I have a sentence in that paragraph with the word CAR, and I change that "R" to a "T" it now reads CAT. That might change the entire meaning of the message to the cell, and it will no longer be able to carry out it’s functions. That would be a pathological mutation and raise the risk of inheriting cancer or of a cell becoming cancerous.  Had I changed the C to a K, and made the word 'KAR', the cell may have still been able to read and understood the word carrying that mutation and can happily continue making the proteins it was supposed to manufacture. This is why some mutations may cause no harm to the cell as long as the cell can still read and understand it’s instructions while other mutations can stop a gene in its tracks, being rendered pathologic. 

This is the simplest way to describe mutations.

A lot of mutations aren't going to matter. You have to mutate them in very specific spots before a cell cant read it. To get a cancer, it's not enough to have one mutation. You have to have one or more specific mutations to enable cells to divide uncontrollably. Then you've got to have a mutation that allows it to get out of the organ that it's in (such as a milk duct) and escape into the nearby adjacent tissues, forming a tumor. That's a whole other gene that has to be bad. You have to have a gene in there that allows those cells to bring in their own blood supply so they can keep the tumor fed and alive.. So that's yet another genetic mutation.

Like with breast cancer, people don’t die of the breast cancer in their breast. They die if it traveled into their entered their bloodstream and lodged in their lungs, it lodged in their liver, it lodged in their bones it lodged in their brain... if it had the mutations it needed to escape the breast and lodge in an organ system that you need. In order to do that it that takes a whole other set of genetic mutations. We can test the tumors for these mutations.  Putting a garden variety breast cancer cell in the lung (per se), may be sort of like putting a Palm tree in Alberta, Canada. You can put a Palm tree up there, unless it has a set of very specific genetic mutations, it's not going to survive the winter up there.

“IT’S NOT THAT EASY TO GET CANCER”:
So that's why all of us aren't running around with cancers. 1 in 8 women will develop breast cancer over their lifetimes. We have genetic mutations that we accumulate, a lot of them meaningless. Then the other thing is you've got to have the exact right mutations all lined up in a row for something to become cancerous. For the same reason not all firefighters in 9/11 die of cancer, it also depends on genetic predisposition and a person’s ability to protect from and heal environmental insults.  We see families where it seems everybody's getting cancer but we can't find a nice single smoking gun or a silver bullet that “caused” it. If cancer were a single process or silver bullet, we’d have it cured already. We're going to have cancer forever because you can't stop the body from mutating or accumulating genetic damage. If you could, we would all be immortal.

So that's the briefest of the basics. Understanding cancer from the angle of genetic mutation and  predisposition helps you see why some people get it, some people don't. Some people may not have the robust repair mechanisms or the lifestyle to fight it off.  Many are sedentary-- they don't exercise, they drink alcohol, or have other lifestyle risks that are another part of it. 

There are also a lot of environmental factors that can turn genes on and turn genes off. That’s a whole other layer. You can be predisposed because you carry a unique malfunctioning gene ... which carries a variable increase in somebody's risk.  They may have a 40% risk they're going to get cancer- or you can see it as that there's 60% risk they never will. We have proto-oncogenes that must be turned on to cause a tumor to form, and tumor suppressor genes that must be turned off to allow a cancer to form. We may or may not be exposed to the environment inside or outside the body that's going to turn it on - or off.



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ABOUT THE AUTHOR:
Awareness for a Cure welcomes our newest cancer expert, Dr. Patricia Clark- Breast and Oncoplastic Surgeon. Dr. Clark is a renowned speaker at the BC3 (National Breast Cancer Conferences) and is currently the medical director and surgical oncologist at the Ironwood Breast Cancer and Research Centers in Scottsdale, AZ. You can learn more about Dr. Clark at: www.drclarkmd.com


Eliminating Cancer is not enough:
A woman’s function and body image matter. For most women, there is no survival advantage to mastectomy. By using oncoplastic techniques such as breast reduction or mastopexy at the time of lumpectomy, selected women with larger tumors or more complex disease can now have complete removal of their cancer and still have a good cosmetic result. While Dr Clark personally performs oncoplastic procedures, high quality plastic surgery consultation is available for all women requiring reconstruction from mastectomy, and to optimize outcomes in selected women undergoing oncoplastic procedures.  Surgery can be performed on the other breast to provide symmetry. We don’t want the breast to be a reminder of cancer in years to come. www.drclarkmd.com


Disclaimer & Copyright Notice: The materials provided on this website/web-based article are copyrighted and the intellectual property of the publishers/producers (The NY Cancer Resource Alliance/IntermediaWorx inc. and Bard Diagnostic Research & Educational Programs). It is provided publicly strictly for informational purposes within non-commercial use and not for purposes of resale, distribution, public display or performance. Unless otherwise indicated on this web based page, sharing, re-posting, re-publishing of this work is strictly prohibited without due permission from the publishers.  Also, certain content may be licensed from third-parties. The licenses for some of this Content may contain additional terms. When such Content licenses contain additional terms, we will make these terms available to you on those pages (which his incorporated herein by reference).The publishers/producers of this site and its contents such as videos, graphics, text, and other materials published are not intended to be a substitute for professional medical advice, diagnosis, or treatment. For any questions you may have regarding a medical condition, please always seek the advice of your physician or a qualified health provider. Do not postpone or disregard any professional medical advice over something you may have seen or read on this website. If you think you may have a medical emergency, call your doctor or 9-1-1 immediately.  This website does not support, endorse or recommend any specific products, tests, physicians, procedures, treatment opinions or other information that may be mentioned on this site. Referencing any content or information seen or published in this website or shared by other visitors of this website is solely at your own risk. The publishers/producers of this Internet web site reserves the right, at its sole discretion, to modify, disable access to, or discontinue, temporarily or permanently, all or any part of this Internet web site or any information contained thereon without liability or notice to you.

Monday, September 10, 2018

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): "Where we are, and aren’t"

By: Constantine Kaniklidis Medical Research (Cancer Knowledge network) & Director of No Surrender Breast Cancer Foundation (NSBCF)-- circa 2018, September

SEE BIA-ALCL FEATURE @ NEWS1
Here some reflections, and a plea for further, more systematized and coordinated action and consensus:

First, the just published LYSA Registry data from the French Cancer Agency [reported at ASCO 2018] has shed some further light on two prognostically distinct classes of BIA-ALCLs (based on effusion, breast tumor mass, and lymph node involvement), with in situ BIA-ALCLs exhibiting an indolent clinical course that enables complete remission typically after implant removal, in contrast to infiltrative BIA-ALCLs exhibiting a more aggressive clinical course, with in fact a prognosis virtually identical to systemic anaplastic large cell lymphoma (ALCL), despite real differences. Further clarification was provided in AU-NZ studies [especially Loch-Wilkinson, Plast Reconstr Surg. 2017 Oct], higher-surface-area (HAS) textured implants significantly increased the risk of BIA-ALCL (over 14 times higher with Biocell textured implants and almost 11 times higher with polyurethane (Silimed) textured implants compared with Siltex textured implants, so there clearly is a risk hierarchy at play here.

Second, being mindful of overtreatment (always a concern), nonetheless given that BIA-ALCL related death, although rare, is predominantly due to uncontrolled local disease progression, there is a role in patients with more advanced local disease – particularly in the minority of patients whose disease extends beyond the capsule – for chemotherapeutic intervention, and at this time the best evidenced first-line therapy apart from the strongly toxic CHOP family of regimens is the monoclonal antibody brentuximab vedotin (Adcetris) based on its role in refractory in ALCL, despite the limited but still positive data of its off-label use in BIA-ALCL; and I have seen some cases of patients progressing on CHOP therapy but achieving pathological complete response (pCR) with brentuximab vedotin in the second line. Given its comparatively favorable side effect profile and higher tolerability over traditional chemotherapies, it retains some considerable appeal.

Third, for myself, given that:
(1) the NF-kB) pathway is commonly deregulated in lymphomas, and that
(2) curcumin can inhibit growth of these cell lines and increase their chemosensitivity to cisplatin, and given also that
(3) it (curcumin) increases apoptosis and differentiation of vitamin D-treated tumor cells, with direct binding of curcumin to the vitamin D receptor (VDR), and that
(4) curcumin modulates the well-known overexpression of EZH2 in anaplastic lymphomas and can down-regulate the  JAK/STAT pathway that is also incriminated in BIA-ALCL, then I have (strictly ad hoc-ly and off-label) counseled the deployment, with provisional but promising success, of a regimen of high-penetrance curcuminoids (either phytosomal or nanoparticulate) and optimal-dosed Vitamin D3 (achieving 25(OH)D assay levels of at least 66 ng/ml and above), in the small number of BIA-ALCL cases I have consulted on, but clearly this requires validation in clinical trial. And Mark Clemens' recent findings suggesting that some BIA-ALCL are associated with a chronic allergic immune response to currently undetermined antigen(s) - with IL-13 activity (associated with allergic inflammation) as well as eosinophils and mast cells surrounding the BIA-ALCL tumors plus the presence of IgE – is tantalizing in this connection of anti-inflammatory interventions.

Going Forward, Work Still To Do:
1.     I am also looking to press for the expansion of the European Commission Medical Device Expert Group (VMDEC) Task Force with respect to collection and analysis of EU-based BIA-ALCL cases, but VMDEC registry data must be coordinated with other non-EU entities – like the PROFILE Registry maintained by the The Plastic Surgery Foundation here in the States, the Australian Breast Device Registry,  among many others – if we are to establish a larger and more comprehensive cross-boundary collaborative BIA-ALCL surveillance initiatives to advance our knowledge and better serve the many women affected (and often overlooked and sometimes misdiagnosed as Hodgkin lymphoma or other entities).

2.     It is disconcerting that we still, even in 2018, lack consistent standardization and reporting regarding pathological examination of mammary implants (most institutions often continue to recommend gross examination alone).

3.     Furthermore, we are not doing enough to educate patients and their health professionals on the importance of routine surveillance after implantation.

4.     And we must finally – long overdue -bring explicit consent issues to the fore to assure fairness to patients. It would appear that most breast-focused plastic surgeons in the U.S. and the UK fail to consistently include risk of BIA-ALCL and that uniform informed-consent documents lack widespread adoption and use, so a model BIA-ALCL informed consent is required and effective efforts made to assure that the patient is not simply “allowed” to read and decipher the information as it is found in the informed consent agreement as is all too commonly the case, but that health professionals first openly and candidly discuss not only the risk of BIA-ALCL but also the common presenting symptoms (a mass, breast swelling/pain, or delayed-presentation seroma / effusion) of BIA-ALCL the patient should be on guard for which would trigger a mandated evaluation. I call this the need for “informed discussion” in addition to mere “informed consent”, and that need was best put by the UK High Court (Judgement in Montgomery ‘v’ Lanarkshire Health Board) that stated that “risk shouldn't be a numbers game, it should be part of dialogue”.

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Constantine Kaniklidis of evidencewatch.com
Director, Medical Research, No Surrender Breast Cancer Foundation (NSBCF)
Oncology Reviewer, Current Oncology
Member, Society for Integrative Oncology (SIO)
European Association for Cancer Research (EACR)


Disclaimer & Copyright Notice: The materials provided on this website/web-based article are copyrighted and the intellectual property of the publishers/producers (The NY Cancer Resource Alliance/IntermediaWorx inc. and Bard Diagnostic Research & Educational Programs). It is provided publicly strictly for informational purposes within non-commercial use and not for purposes of resale, distribution, public display or performance. Unless otherwise indicated on this web based page, sharing, re-posting, re-publishing of this work is strictly prohibited without due permission from the publishers.  Also, certain content may be licensed from third-parties. The licenses for some of this Content may contain additional terms. When such Content licenses contain additional terms, we will make these terms available to you on those pages (which his incorporated herein by reference).The publishers/producers of this site and its contents such as videos, graphics, text, and other materials published are not intended to be a substitute for professional medical advice, diagnosis, or treatment. For any questions you may have regarding a medical condition, please always seek the advice of your physician or a qualified health provider. Do not postpone or disregard any professional medical advice over something you may have seen or read on this website. If you think you may have a medical emergency, call your doctor or 9-1-1 immediately.  This website does not support, endorse or recommend any specific products, tests, physicians, procedures, treatment opinions or other information that may be mentioned on this site. Referencing any content or information seen or published in this website or shared by other visitors of this website is solely at your own risk. The publishers/producers of this Internet web site reserves the right, at its sole discretion, to modify, disable access to, or discontinue, temporarily or permanently, all or any part of this Internet web site or any information contained thereon without liability or notice to you.

Thursday, August 9, 2018

To Reconstruct or NOT to Reconstruct... That is the Question

An excerpt from "​Breast Cancer Survival Guide" by: Lisa Vento Nielsen

When you are preparing for a mastectomy, part of the process is meeting with a plastic surgeon as one of the "benefits" of getting breast cancer is new boobs. Even if just one boob is trying to kill you, you can get the poisoned one replaced and the other one can be lifted and improved, too - all covered by insurance (if you are lucky enough to have insurance, of course).

I kind of felt from before I was even diagnosed at each screening mammo that I would not reconstruct. I always felt just the idea of boobs and dealing with the screening was work enough and often thought we should all just get the boobs removed because what is the point of carrying around things that so obviously is unclear as to what causes them to get diseased. As I mentioned,  I have no history of the disease and no known risk factors and yet here I am someone with dealing with breast cancer.

I am lucky though - lucky that I had screening mammos that began at 34 and not the new ruling of 40 and up because I was diagnosed literally on the eve of my 40th birthday after some inflamed ducts at my screening at 38 put me on the 6 month squeeze plan. From my previous scan at 38 that showed minor inflammation in the duct of my right breast, which is common to breast feeding and too small to biopsy oh and had a 99% chance of staying benign was within 6 months a tumor and definitely malignant.

It would ultimately turn out to be 5.6cm of cancer with 5 of 25 lymph nodes infections - otherwise knows as Stage 3 Cancer. From diagnosis to surgery, I had only 17 days. 17 days to figure out what exactly was going on in my body - all of which was truly not known until I was operated on but more on that journey in another post.

For now, the perks of breast cancer is getting that appointment with the surgeon to pick out your new boobs. I was first told about this new process by which they take fat from other parts of your body to reconstruct your breast and when the surgeon asked to see me disrobed, her first words were "You are obviously not a candidate for the fat shifting procedure." And I said, "Why because I am too skinny??" Note: I have never been too skinny for anything. She stared at me and said, "No - it is just too risky for you with xyz condition."

On that note, I was shown before and after pictures of her work and although impressive, I did not see me in those pictures. As someone who since puberty did enjoy having boobs and wearing low cut tops now as a mom of 2 and someone whose decollete was trying to kill me, I was really in the flat camp for boobs.

I did not think it through as clearly as I could have as I was going to still have a boob - and be uneven in an extreme way. I always had one boob that was bigger than the other but I did not really process how I would now just have one boob. Period.

The nurse in the office did try to get me to see the error of my ways - she said the normal about how I was so young and would want to have the appearance of two breasts and even the office acknowledges that the surgery does not give you a normal breast - just the appearance in clothes of having normal breasts.

It seems all selfish of me to put myself under for a longer amount of time, to delay my chemotherapy and to go in for additional surgeries just to have the appearance of breasts. I was ultimately at peace with refusing the reconstruction of the diseased boob and makeover of the other.

Now, I will not say I regret it but having to do these extra steps to be people-ready is very annoying. I would often run out without wearing a bra even though my boobs were not perky and camera ready and one thing I really do lament is not getting a picture of my boobs when I had the pair I was born with but you do not get to where I have been in life without learning the issues of leaked nude photos so I just have the pics of cleavage that I often showed and no real idea of what the missing boob really looked like besides a faint memory.

Over all, I am happy with my one boob and my prosthetic but I do see maybe down the road going for the reconstruction (one other perk is you can do it at a later date, if you so choose so the window on my reconstructing is not yet closed).

The key is beating the disease, of course, but sometimes, you really want to look hot doing it and it can be hard to look hot when you are lopsided because your prosthetic won't sit right in its pocket. Just something else to manage in the time between.

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ABOUT THE AUTHOR
Lisa Vento Nielsen, MBA, PMP is a speaker, author, career expert and cancer survivor. She has expertise and first hand experience in how to get back to “normal” after illness. Her blogs and writings are read by over 2000 people per week. She created a nonprofit foundation focused on educating cancer survivors on getting their balance after cancer.  Lisa is also a volunteer and ambassador of NYCRA (NY Cancer Resource Alliance), a contributing writer in the 911Cancer Resource website and has recently been elected to co-manage the Awareness for a Cure's post- cancer educational program.



Disclaimer & Copyright Notice: The materials provided on this website/web-based article are copyrighted and the intellectual property of the publishers/producers (The NY Cancer Resource Alliance/IntermediaWorx inc. and Bard Diagnostic Research & Educational Programs). It is provided publicly strictly for informational purposes within non-commercial use and not for purposes of resale, distribution, public display or performance. Unless otherwise indicated on this web based page, sharing, re-posting, re-publishing of this work is strictly prohibited without due permission from the publishers.  Also, certain content may be licensed from third-parties. The licenses for some of this Content may contain additional terms. When such Content licenses contain additional terms, we will make these terms available to you on those pages (which his incorporated herein by reference).The publishers/producers of this site and its contents such as videos, graphics, text, and other materials published are not intended to be a substitute for professional medical advice, diagnosis, or treatment. For any questions you may have regarding a medical condition, please always seek the advice of your physician or a qualified health provider. Do not postpone or disregard any professional medical advice over something you may have seen or read on this website. If you think you may have a medical emergency, call your doctor or 9-1-1 immediately.  This website does not support, endorse or recommend any specific products, tests, physicians, procedures, treatment opinions or other information that may be mentioned on this site. Referencing any content or information seen or published in this website or shared by other visitors of this website is solely at your own risk. The publishers/producers of this Internet web site reserves the right, at its sole discretion, to modify, disable access to, or discontinue, temporarily or permanently, all or any part of this Internet web site or any information contained thereon without liability or notice to you.

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